Valve treatment devices, systems, and methods

ABSTRACT

Medical device systems, methods and devices are provided for treating a valve in a heart to minimize valve regurgitation, the medical device system includes an RF energy source, a handle, a treatment catheter, and first and second sleeves. The handle is operatively coupled to the RF energy source and coupled to the treatment catheter. The first and second sleeves each extend through a lumen of the treatment catheter and are moveable between a constricted position and an expanded position. The first sleeve includes a first electrode and the second sleeve includes a second electrode. Further, the first sleeve and the second sleeve are biased away from each other such that, upon being moved to the expanded position, the first and second sleeves splay outward to exhibit a v-configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. ProvisionalApplication No. 61/874,313, filed Sep. 5, 2013, and U.S. ProvisionalApplication No. 61/895,478, filed on Oct. 25, 2013, the disclosures ofwhich are hereby incorporated by reference in their entirety. Thisapplication relates to U.S. patent application Ser. No. 14/475,540,filed Sep. 2, 2014, titled VALVE TREATMENT DEVICES, SYSTEMS, ANDMETHODS, the disclosure of which is hereby incorporated by reference inits entirety.

TECHNICAL FIELD

The present invention relates generally to devices, systems, and methodsfor limiting valve regurgitation. More particularly, the presentinvention relates to medical devices, systems, and methods forpercutaneously treating valves in, for example, the heart to limit valveregurgitation.

BACKGROUND

The human heart generally includes four valves: the mitral valve, thetricuspid valve, the aortic valve, and the pulmonic valve. Although allcritical to heart function, the most critical one is the mitral valve.The mitral valve is located in an opening between the left atrium andthe left ventricle. The mitral valve acts as a check valve and isintended to prevent regurgitation of the blood from the left ventriclein the left atrium when the left ventricle contracts. In preventingblood regurgitation the mitral valve must be able to withstandconsiderable back pressure as the left ventricle contracts.

The valve cusps or leaflets of the mitral valve are anchored to themuscular wall of the heart by delicate but strong fibrous cords so as tosupport the cusps during left ventricular contraction. In a healthymitral valve, the geometry of the mitral valve ensures that the cuspsoverlie or touch each other to preclude regurgitation of the bloodduring left ventricular contraction. In contrast, the geometry isenlarged in an unhealthy mitral valve, which may prevent the leafletsfrom fully closing, resulting in mitral regurgitation.

Many known methods for treating mitral regurgitation resort to openheart surgery, typically by repairing the valve with a device ormodifying the valve. Such procedures are expensive, extremely invasiverequiring considerable recovery time and, most significantly, posemortality risks. Further, such open heart procedures are particularlystressful on patients whom already have a cardiac condition. As such,open heart surgery is typically reserved as a last resort and is usuallyemployed late in the mitral regurgitation progression. Moreover, theeffectiveness of such procedures is difficult to assess during theprocedure and may not be known until a much later time. Therefore theability to make adjustments or modifications to the prostheses in orderto obtain optimum effectiveness is extremely limited. Later corrections,if made at all, require still another open heart surgery bringing all ofthe risks and disadvantages discussed previously.

Other methods for treating mitral regurgitation have been proposed orimplemented with some success, such as percutaneously implanting variousclips in the chordae or at the valve cusps to assist in limiting valveregurgitation or prolapse. Although these methods have had some successand are non-invasive, the procedures are long and cumbersome, oftentaking several hours to complete. Further, due to leaving an implantedmedical device in the heart, should the patient need additionalsubsequent procedures if, for example, regurgitation at the mitral valveagain becomes an issue or the original regurgitation at the mitral valveis not corrected, another implanted device to correct the problem may beimpossible at which time the patient's options may be limited to openheart surgery.

Based on the foregoing, it would be advantageous to employ a lessinvasive procedure to treat mitral regurgitation or any other types ofvalve regurgitation that overcome the disadvantages and issues resultingwith the current invasive and non-invasive heart implants.

A variety of features and advantages will be apparent to those ofordinary skill in the art upon reading the description of variousembodiments set forth below.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to various devices,systems and methods of a medical device system for treating a valve in aheart to minimize valve regurgitation. In one embodiment, the medicaldevice system includes a radio frequency (“RF”) energy source, a handle,a treatment catheter, and first and second sleeves. The handle isoperatively coupled to the RF energy source. The treatment catheter iscoupled to the handle such that the treatment catheter extends between aproximal end and a distal end and includes a lumen defined along alength of the treatment catheter. The first and second sleeves eachextend through the lumen of the treatment catheter and are moveablebetween a constricted or constrained position and an expanded position.The first sleeve includes a first electrode and the second sleeveincludes a second electrode. Further, the first sleeve and the secondsleeve are biased away from each other such that, upon being moved tothe expanded position, the first and second sleeves splay outward toexhibit a v-configuration.

In another embodiment, the first and second electrodes are eachindependently moveable between a proximal position and a distalposition. In another embodiment, the first and second electrodes areeach independently rotatably moveable such that the helicalconfiguration of each of the first and second electrodes is configuredto twist into and out of tissue of the valve.

In another embodiment, the first electrode and the second electrode eachinclude a helical configuration. In still another embodiment, the firstelectrode and the second electrode each include a pointed distal tip. Inyet another embodiment, the first electrode and the second electrodeeach include a needle configuration.

In another embodiment, the first sleeve and the second sleeve are eachdisposed within a tubular sleeve, the tubular sleeve moveable proximallyand distally relative to the first and second sleeves so as to move thefirst and second sleeves between the constrained position and theexpanded position. In still another embodiment, upon the tubular sleevebeing moved proximally relative to distal ends of the first and secondsleeves, the distal ends of the first and second sleeves are apredetermined distance from each other. In another embodiment, thepredetermined distance between the distal ends of the first and secondsleeves in the expanded position is dependent upon a position of adistal end of the tubular sleeve relative to the distal ends of thefirst and second sleeves.

In another embodiment, the first electrode and the second electrode areeach coupled to the RF energy source. In another embodiment, thetreatment catheter is configured to be steerable along a distal portionof the treatment catheter such that the distal portion is moveable tomultiple orientations.

In another embodiment, the medical device system further includes asheath defining a sheath lumen along a length of the sheath, the sheathlumen configured to provide a pathway to position the distal end of thetreatment catheter adjacent the valve. In still another embodiment, themedical device system further includes an imaging member sized andconfigured to be positioned within the valve and configured to provideimaging information regarding valve orientation relative to thetreatment catheter.

In still another embodiment, the treatment catheter includes one or moretemperature sensors. In another embodiment, the treatment catheterincludes a third sleeve configured to extend between the first andsecond sleeves such that the third sleeve includes a temperature sensorconfigured to sense tissue temperature. Further, in another embodiment,the medical device system includes a controller coupled to the RF energysource and the one or more temperature sensors. In yet anotherembodiment, the one or more temperature sensors are associated with eachof the first and second electrodes.

In accordance with another embodiment of the present invention, amedical device system for treating a valve in a heart to minimize valveregurgitation is provided. The medical device system includes an RFenergy source, a handle, a treatment catheter, and first and secondsleeves. The handle is operatively coupled to the RF energy source. Thetreatment catheter is coupled to the handle such that the treatmentcatheter extends between a proximal end and a distal end and includes alumen defined along a length of the treatment catheter. The first andsecond sleeves each extend through the lumen or lumens of the treatmentcatheter such that the first and second sleeves are moveable between aconstricted position and an expanded position and such that the firstand second sleeves include a first electrode and a second electrode,respectively. Further, the first and second electrodes each include ahelical configuration with a sharp distal tip configured to twist intotissue of the valve. Furthermore, the first and second electrodes areeach independently moveable relative to each other with linear androtational movement.

In one embodiment, upon the first and second sleeves being moved to theexpanded position, the first and second sleeves splay outward from eachother to exhibit a v-configuration. In another embodiment, the first andsecond sleeves are positioned within a tubular sleeve and are moveableproximally and distally relative to the tubular sleeve. In still anotherembodiment, the first and second sleeves are positioned within a tubularsleeve and are each independently moveable proximally and distallyrelative to the tubular sleeve. In another embodiment, the first andsecond sleeves are configured to rotatably move together so as to pivotabout one of the first and second sleeves with one of the first andsecond electrodes being secured to tissue. Finally, in antherembodiment, the first and second electrodes operate in at least one of abipolar mode and a unipolar mode.

In still another embodiment, the treatment catheter includes one or moretemperature sensors. In another embodiment, the treatment catheterincludes a third sleeve configured to extend between the first andsecond sleeves such that the third sleeve includes a temperature sensorconfigured to sense tissue temperature. Further, in another embodiment,the medical device system includes a controller coupled to the RF energysource and the one or more temperature sensors. In yet anotherembodiment, the one or more temperature sensors are associated with eachof the first and second electrodes.

In accordance with another embodiment of the present invention, a methodof treating a valve in a heart to minimize valve regurgitation isprovided. The method includes the steps of: advancing a sheath adjacentto the valve; advancing a treatment catheter through the sheath toposition adjacently above the valve; exposing distal ends of a firstsleeve and a second sleeve such that the first and second sleeves splayoutward to exhibit a v-configuration; moving a first electrode from thedistal end of the first sleeve to contact and extend into tissue of thevalve proximately at a first target point; moving a second electrodefrom the distal end of the second sleeve to contact and extend into thetissue of the valve proximately at a second target point; activating thefirst and second electrodes with RF energy from an RF energy source toheat tissue over a first tissue region between the first electrode andthe second electrode; pivoting the first and second sleeves to rotateabout the second sleeve to move the first electrode to contact andextend into the tissue of the valve proximately at a third target point;and activating the first and second electrodes with energy from theenergy source to heat tissue over a second tissue region between thefirst and second electrodes in the tissue.

In another embodiment, the method further includes the step of advancingan imaging loop through the sheath and positioning the imaging loop inthe valve for determining an orientation of the valve. In anotherembodiment, the step of exposing includes withdrawing the treatmentcatheter from the first and second sleeves to move the first and secondsleeves from a constricted position to an expanded position such thatthe first and second sleeves self-expand to the v-configuration. Instill another embodiment, the step of exposing includes withdrawing atubular sleeve from the first and second sleeves to move the first andsecond sleeves from a constricted position to an expanded position suchthat the first and second sleeves self-expand to the v-configuration. Inanother embodiment, the step of withdrawing includes withdrawing thetubular sleeve a pre-determined length that corresponds to apredetermined lateral distance between distal ends of the first andsecond sleeves.

In another embodiment, the step of moving the first electrode includesrotatably moving the first electrode having a helical configuration totwist the first electrode into the tissue of the tissue; and the step ofmoving the second electrode includes rotatably moving the secondelectrode having a helical configuration to twist the second electrodeinto the tissue of the tissue.

In another embodiment, the method further includes, prior to the step ofpivoting, withdrawing the first electrode from the tissue to facilitatethe pivoting of the first and second sleeves about the second sleeve. Inanother embodiment, the method further includes pivoting the first andsecond sleeves to rotate about the first sleeve to move the secondelectrode to contact and extend into the tissue of the valve proximatelyat a fourth target point; and activating the first and second electrodeswith RF energy from the RF energy source to heat tissue over a thirdtissue region between the first and second electrodes in the tissue.

In another embodiment, the method further includes controlling anorientation of a distal portion of the treatment catheter with asteerable mechanism associated with a handle of the treatment catheter.In still another embodiment, the method further includes sensing atemperature of the tissue with one or more temperature sensors. Inanother embodiment, the method steps of activating include heating thetissue between the first and second electrodes to a temperature in therange of 50-85 degrees Celsius. In yet another embodiment, the methodstep of heating includes controlling the RF energy source fromoverheating the tissue with a controller coupled to one or moretemperature sensors.

These various embodiments may include other components, features or actsas will be apparent from the detailed description set forth below.Additionally, other embodiments, configurations and processes are setforth below in the detailed description of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other advantages of the invention will become apparentupon reading the following detailed description and upon reference tothe drawings in which:

FIG. 1 is a perspective view of a medical device system, depicting an RFenergy source and controller in schematic form, according to anembodiment of the present invention;

FIG. 1A is a cross-sectional view of the sheath and treatment cathetertaken along section line 1A of FIG. 1, according to another embodimentof the present invention;

FIG. 2A is a schematic of the RF energy source and a unipolar electrodesystem, according to one embodiment of the present invention;

FIG. 2B is a schematic of the RF energy source and a bipolar electrodesystem, according to another embodiment of the present invention;

FIG. 3 is a perspective view of a distal portion of the medical devicesystem, depicting the distal portion of a sheath, an imaging member, anda treatment catheter, according to another embodiment of the presentinvention;

FIG. 3A is a perspective view of another embodiment of the distalportion of a treatment catheter, depicting the electrodes having aneedle configuration, according to the present invention;

FIG. 3B is a perspective view of another embodiment of the distalportion of a treatment catheter, depicting a portion of a unipolarelectrode system, according to the present invention;

FIG. 3C is a perspective view of another embodiment of a distal portionof a treatment catheter, depicting a temperature sensor positionedbetween two electrodes, according to the present invention;

FIG. 4 is a cross-sectional view of a heart, depicting a partiallydeployed imaging member extending from a sheath advanced through aseptum of the heart, according to another embodiment of the presentinvention;

FIG. 5 is a simplified cross-sectional view of a left side of the heart,depicting the imaging member positioned in a mitral valve of the heart,according to another embodiment of the present invention;

FIG. 5A is a simplified top view of the mitral valve with the imagingmember positioned therein, according to another embodiment of thepresent invention;

FIG. 6 is a simplified top view of the mitral valve, depicting a distalportion of a treatment catheter extending toward a first tissue regionof the mitral valve, according to another embodiment of the presentinvention;

FIG. 6A is a side view of the distal portion of the treatment catheter,depicting a first sleeve positioned against the mitral valve, accordingto another embodiment of the present invention;

FIG. 6B is a side view of the distal portion of the treatment catheter,depicting a first sleeve and a second sleeve positioned against themitral valve with a first and second electrode moved distally to contactthe mitral valve, according to another embodiment of the presentinvention;

FIG. 7 is a simplified top view of the mitral valve, depicting first andsecond electrodes contacting the mitral valve, according to anotherembodiment of the present invention;

FIG. 7A is a side view of the distal portion of the treatment catheter,depicting the treatment catheter pivoting about the second sleeve,according to another embodiment of the present invention;

FIGS. 8, 9 and 10 are a simplified top views of the mitral valve,depicting the first and second electrodes positioned to heat respectivesecond, third, and fourth tissue regions, according to anotherembodiment of the present invention;

FIG. 11 is a simplified top view of the mitral valve, depicting thetreatment catheter withdrawn from the mitral valve, according to anotherembodiment of the present invention;

FIG. 12 is a perspective view of another embodiment of a medical device,depicting the medical device fully deployed from the treatment catheterand having a weave configuration, according to the present invention;

FIG. 12A is a cross-sectional view of the medical device taken alongsection line 12A of FIG. 12, according to another embodiment of thepresent invention;

FIG. 13 is a simplified view of the medical device partially deployedfrom the treatment catheter, depicting the medical device positionedover the imaging member, according to another embodiment of the presentinvention;

FIG. 14 is a simplified view of the medical device fully deployed over amitral valve, depicting a periphery of the medical device havingelectrodes positioned over the posterior annulus and anterior annulus ofa valve, according to another embodiment of the present invention;

FIG. 15 is a block diagram of method steps for treating a valve in theheat, according to another embodiment of the present invention;

FIG. 16 is a perspective view of another embodiment of a medical device,depicting the medical device having an expandable and retractable loopconfiguration, according to the present invention;

FIG. 16A is a perspective view of the medical device of FIG. 16,depicting the medical device in a constricted position within thetreatment catheter, according to another embodiment of the presentinvention;

FIG. 17 is a perspective view of the medical device of FIG. 16,depicting the medical device partially deployed over a posterior annulusof a valve, according to another embodiment of the present invention;

FIG. 18 is a perspective view of the medical device of FIG. 16,depicting the medical device fully deployed over the posterior annulusof the valve, according to another embodiment of the present invention;

FIGS. 19 and 20 are perspective views of another embodiment of a medicaldevice, depicting the medical device having an arcuate configurationwith a pusher/puller portion, according to the present invention;

FIG. 20A is a cross-section view of the medical device taken alongsection line 20A of FIG. 20, depicting the arcuate configuration of themedical device, according to the present invention;

FIG. 21 is a front view of another embodiment of a medical device,depicting the medical device having a ring configuration in a firstorientation, according to the present invention; and

FIG. 22 is a side view of the medical device, depicting the medicaldevice moved to a second orientation, according to another embodiment ofthe present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring first to FIG. 1, a medical device system 10 for treating valveregurgitation is provided. The medical device system 10 may include atreatment catheter system 12, a sheath 14, and a radio frequency (“RF”)energy source 16. The RF energy source 16 may also be coupled to acontroller 18 such that the controller 18 may be housed with the RFenergy source 16. With such a medical device system 10, a distal portionof the sheath 14 may be advanced and positioned in the left atrium ofthe heart so that the treatment catheter system 12 may then be advancedthrough the sheath 14 to, for example, a valve in the heart, such as amitral valve 170 (see FIG. 4). The treatment catheter system 12 mayinclude one or more electrodes to be positioned to contact tissue of thevalve, for example, the tissue of the posterior annulus of the valve.The one or more electrodes may be employed to heat the tissue of thevalve to a predetermined temperature range with the RF energy source 16at energy levels that may be modulated for a period of time. With thisarrangement, the medical device system 10 may treat the valve by heatingthe tissue of the annulus, which results in the tissue shrinking,thereby, restoring the valve to normal size and function and tosubstantially reduce or prevent valve regurgitation.

Now referring to FIGS. 1 and 1A, as set forth, the medical device system10 may include a sheath 14. The sheath 14 may be sized and configured toreceive a treatment catheter 20 of the treatment catheter system 12 and,as such, the sheath 14 may be somewhat shorter in length than thetreatment catheter 20. The sheath 14 may extend between a proximal end22 and a distal end 24 with a sheath lumen 26 defined along a length ofthe sheath 14. The sheath 14 may include a sheath hub 28 and a sheathflush port 30. The sheath hub 28 may be coupled to the proximal end 22of the sheath 14, the sheath hub 28 including a bore (not shown) definedtherein that extends co-axial with the sheath lumen 26. Further, thesheath hub 28 may incorporate a hemostasis valve 32 such that thehemostasis valve 32 may be rotated, for example, clockwise to betightened over the treatment catheter 20 and rotated counter-clockwiseto be loosened over the treatment catheter 20. Such a hemostasis valve32 may be employed to minimize blood back-flow from a patient when thesheath 14 and the treatment catheter 20 are positioned within a patent'svascular system.

The sheath flush port 30 may extend from the sheath hub 28 or adjacentlydistal of the sheath hub 28. The sheath flush port 30 may be employed toflush the sheath 14 to minimize potential air pockets and air bubblesalong the sheath lumen 26 of the sheath 14. Further, such sheath flushport 30 may be employed to inject contrast into the left atrium forviewing the mitral valve. The sheath 14 may include other structuralfeatures to assist in advancing the treatment catheter 20 to the mitralvalve, as known to one of ordinary skill in the art.

Now referring to the treatment catheter system 12, such treatmentcatheter system may include the before referenced treatment catheter 20and a handle 34 with various actuation members associated with thehandle 34. Further, the treatment catheter system 12 may be coupled tothe RF energy source 16 and the controller 18. The treatment catheter 20may extend between a distal end 36 and a proximal end 38 and define anaxis 40 and a primary lumen 42 extending along a longitudinal length ofthe treatment catheter 20. The treatment catheter 20 may include atubular sleeve 44 or electrode outer sleeve that also defines a tubularsleeve lumen 46 along a length thereof, the tubular sleeve 44 extendingthrough the primary lumen 42 along the axis 40 of the treatment catheter20. As depicted in FIG. 1A, the tubular sleeve lumen 46 may include acircular cross-sectional shape or profile, however, such profile mayalso be rectangular, oval, tri-lobular, or any other suitablecross-sectional profile.

Further, the treatment catheter 20 may also include a first sleeve 48and second sleeve 50 each extending alongside each other within thetubular sleeve lumen 46 and along the length of the treatment catheter20. The first and second sleeves 48, 50 may also be referenced as firstand second electrode sleeves or first and second inner sleeves. In oneembodiment, the first sleeve 48 and the second sleeve 50 may beelectrically isolated from each other and may each include a respectivefirst electrode 52 and a second electrode 54. The first and secondelectrodes 52, 54 may extend from a distal end of the first and secondsleeves 48, 50, respectively, and be electrically coupled to the RFenergy source 16. In one embodiment, the treatment catheter system 12may operate in a unipolar mode. In another embodiment, the treatmentcatheter system 12 may operate in a bipolar mode.

FIGS. 2A and 2B illustrate general representations of the medical devicesystem operating in a unipolar mode (FIG. 2A) and a bipolar mode (FIG.2B). For example, FIG. 2A represents an electrode system 60 operating ina unipolar mode, the system 60 including at least one electrode 62, suchas the first and second electrodes previously set forth or other elementwhich can serve as an electrode, in electronic communication with an RFenergy source 16A or RF generator via an electronic coupling element 64,such as a wire or electronic cable. In unipolar mode, the systemincludes a return electrode or ground 66. The ground 66 can bepositioned on the patient's skin, or alternatively, can be a pad onwhich a patient rests. It will be understood that the electrode 62 caninclude multiple electrodes which are electrically common elements, suchthat RF energy can be transferred from the electrodes to the ground 66.The ground 66 can be electrically coupled to the RF energy source 16A byan electronic coupled element 68, such as a wire or electronic cable.

In bipolar mode, as illustrated in FIGS. 1 and 2B, an electrode system70 can include the first electrode 52 electrically coupled to the RFenergy source 16 or RF generator by an electronic coupling element 72,such as a wire or electronic cable, and the second electrode 54electrically coupled to the RF energy source 16 or RF generator by anelectronic coupling element 74, such as a wire or electronic cable. Inthis manner, RF energy can be passed between the first and secondelectrodes 52, 54, rather than from the electrodes to a ground, as inthe unipolar mode or configuration. It will be understood in view of thedisclosure provided herein that the first electrode 52, the secondelectrode 54, and/or electrode 62 can include one or more electricallycommon electrodes or elements. As known to one of ordinary skill in theart, the RF energy source 16 may be any suitable RF energy generatorconfigured to pass RF energy to the first and second electrodes 52, 54sufficient to heat the tissue at controlled levels. In otherembodiments, rather than an RF energy source as discussed herein, themedical device system 10 may include another type of energy source forheating the tissue, such as, employing ultrasound, high frequencyultrasound, lasers, microwave, or any other suitable energy for heatingthe tissue.

The RF energy source 16 may modulate at various energy levels. Forexample, such levels may include modulating the RF energy source between0-100 watts to heat the tissue in the range of 50-85 degrees Celsius andpreferably within the range of 60-70 degrees Celsius. In one embodiment,the preferable heating of the tissue may be about 65 degrees Celsius.Dependent upon the level of RF energy applied by the RF energy source16, such heating of tissue may be implemented over a time period in therange of about twenty seconds to five minutes. In one embodiment, the RFenergy applied to the tissue may be modulated to facilitate applying theRF energy for about one minute to reach the preferred temperature rangesfor heating the tissue.

Now with reference to FIG. 1, the RF energy source 16 may also becoupled to a controller 18. The controller 18 may be configured tocontrol the RF energy applied by the RF energy source 16 based ontemperature readings of the tissue receiving the RF energy. For example,the treatment catheter 20 may include one or more temperature sensors(not shown) positioned at the distal end thereof and adjacent the one ormore electrodes, discussed in further detail herein. The controller 18may be coupled to the RF energy source 16 and to the one or moretemperature sensors so as to control the RF energy applied (amount andduration) to the electrodes based on the temperature readings from thetissue being treated. In this manner, the controller 18 associated withthe RF energy source 16 may assist in controlling the RF energy source16 to ensure the tissue is heated to the desired temperature withoutoverheating the tissue of the valve.

Referring now to FIGS. 1 and 3, various components of the medical devicesystem 10 will now be discussed in greater detail. In one embodiment,the medical device system 10 may include an imaging member 80 or imagingloop. The imaging member 80 may be advanced through the sheath lumen 26prior to advancing the treatment catheter 20 therethrough. In anotherembodiment, the imaging member 80 may be advanced through peripherallumens 81 defined in and extending longitudinally through the wall ofthe sheath 14. In another embodiment, the imaging member 80 may bedisposed within peripheral lumens defined in the wall of the treatmentcatheter 20 so that the imaging member 80 is advanced simultaneouslywith the treatment catheter 20.

The imaging member 80 may be sized and configured to self-orient and bepositioned within a valve, such as a mitral valve, shown in detailhereafter. The imaging member 80 may be in the form of a wire or a coilor the like. The imaging member 80 may be sized and configured to beconstricted within the sheath 14 for advancing therethrough and, onceexposed from a distal end 24 of the sheath, may self-expand to apreformed shape at a distal portion of the imaging wire 80. Thepreformed portion or distal portion of the imaging member 80 may includea head portion 82 and first and second shoulder portions 84, 86. Forexample, the head portion 82 may include a dome shaped profile withproximal ends of the head portion 82 each extending to the respectivefirst and second shoulder portions 84, 86. The first and second shoulderportions 84, 86 may extend laterally outward relative to the proximalends of the head portion 82. From the first and second shoulder portions84, 86, the imaging member 80 may include first and second extensions88, 90 that are sized and configured to extend proximally toward andthrough the sheath lumen 26 defined in the sheath 14. The head portion82 and the first and second shoulder portions 84, 86 may be configuredto be planar or disposed in a common plane so as to resist out-of-planemovement, but also be readily able to flex inward and outward within theplane of the imaging member 80 to compensate for the various sizes ofmitral valves. Other suitable configurations may also be employed thatwill self-center or self-orient within a given valve to provide aphysician information utilizing imaging techniques, such as theorientation, sizing, and depth of the valve being treated.

The imaging member 80 may be formed from a metallic or polymericmaterial, such as a super-elastic material that is suitable forconstriction within the sheath 14 and self-expands once exposed from thesheath 14. In the case of a super-elastic metallic material, such asNitinol, the head and shoulder portions of the imaging member 80 may beformed utilizing, for example, heat-setting techniques at particulartemperatures in, for example, a sand bath or salt bath as known to oneof ordinary skill in the art. The imaging member 80 may also be formedof a polymeric material or the combination of polymeric and metallicmaterials, formed as a braid or coil or utilizing machining/lasercutting techniques to form various portions of the imaging member 80 tohold structural characteristics of varying flexibility, as known to oneof ordinary skill in the art.

The imaging member 80 may also include a radiopaque material. Suchradiopaque material holds a material density to facilitate viewing theimaging member utilizing imaging techniques, as known in the art, as theimaging member is advanced through the sheath, deployed, and positionedwithin a given valve. The imaging member may include markers 92 at keylocations along, for example, the head portion 82 and/or first andsecond shoulder portions 84, 86. In another embodiment, the imagingmember 80 may include a coating or layer of radiopaque material overboth the head portion 82 and the first and second shoulder portions 84,86, and any other desired portions of the imaging member 80. In anotherembodiment, the imaging member 80 may include radiopaque markers 92 atkey locations as well as a radiopaque coating formed as a thin layerover portions of the imaging member 80. Any suitable highly denseradiopaque material may be employed, such as, titanium, tungsten, bariumsulfate, and zirconium oxide, platinum, platinum iridium, tantalumand/or combinations thereof.

As previously set forth, the treatment catheter system 12 may includethe handle 34 coupled to the treatment catheter 20, the treatmentcatheter 20 including each of the tubular sleeve 44, and first andsecond sleeves 48, 50 disposed therein. The proximal end 38 of thetreatment catheter 20 may be fixedly coupled to and within a bore (notshown) of the handle 34. The handle 34 may include a fluid flush port 94for flushing the treatment catheter 20 of any air bubbles or air pocketswithin the treatment catheter 20 and handle 34, as known in the art.Further, the handle 34 may include a steering actuator 96, an engagingswitch 98, and an electrode actuation system 100, each serving one ormore functions in controlling or actuating various portions of thetreatment catheter 20, tubular sleeve 44, first and second sleeves 48,50, and/or the first and second electrodes 52, 54.

Referring to FIGS. 1 and 1A, for example, the steering actuator 96 maybe in the form of a joy-stick. The steering actuator 96 may be sized andconfigured to manipulate a distal portion of the treatment catheter 20so as to facilitate orienting the distal end 36 of the treatmentcatheter 20 in a direction adjacent to a tissue region to be treated at,for example, a mitral valve. In one embodiment, the steering actuator 96may be coupled to one to four lines or wires extending to a distalportion of the treatment catheter 20, or any number of suitable lines toeffect steering the distal portion of the treatment catheter 20. Forexample, the steering actuator 96 may include two pair of lines or wiresor more extending longitudinally from the handle 34 and throughperipheral lumens 106 defined in the wall of the treatment catheter 20.Each pair of lines may longitudinally extend through the peripherallumens 102 along opposing sides of the wall so as to manipulate movementof a distal portion of the treatment catheter 20. For example, a firstpair of lines 104 may manipulate the distal portion of the treatmentcatheter 20 in a first plane 108. Likewise, a second pair of lines 106may manipulate the distal portion of the treatment catheter 20 in asecond plane 110. With this arrangement, the distal portion of thetreatment catheter 20 may be steered (or moved to an arcuateorientation) along the first and second planes 108, 110 as well as acombination of the first and second planes 108, 110 so as to activatetwo adjacent lines from the first and second pair of lines 104, 106 tosteer the distal portion of the treatment catheter 20 to an arcuateorientation extending between the first and second planes 108, 110.

In one embodiment, the distal portion of the treatment catheter 20 maybe sized and configured with a lower durometer than other portions ofthe treatment catheter 20 such that the distal portion has a greaterflexibility than the other portions of the catheter 20. Such greaterflexibility may readily facilitate moving and steering the distalportion of the treatment catheter 20 in various arcuate positions. Thesteering actuator 96 may include the joy-stick configuration such thatthe joy-stick extends orthogonal relative to the axis 40 of thetreatment catheter 20, as depicted. In another embodiment, the joy-stickmay extend with an orientation parallel, transversely alongside, orco-axial with the axis 40 of the treatment catheter 20. Otherconfigurations and structures for the steering actuator may also beemployed that are inherently intuitive for controlling the orientationof the distal portion of the treatment catheter 20.

Now with reference to FIG. 1, the engaging switch 98 at the handle 34may be disposed directly on the handle. Further, the engaging switch 98may be moved between an engagement position and an open position. In theengagement position, the various components/functions of the electrodeactuation system 100 may be locked from linear and/or rotationalmovement. On the other hand, in the open position, the components of theelectrode actuation system 100 may be operated for linear and/orrotational movement. In one embodiment, the engaging switch 98 may beactuated by moving the switch distally or proximally between theengagement position and the open position, respectively. In anotherembodiment, the engaging switch 98 may be depressed to the open positionand include a spring bias to automatically move the engaging switch 98to the closed position upon removing downward pressure to the engagingswitch 98. In another embodiment, the handle 34 may include a pluralityof engaging switches for controlling actuation of the various componentsof the electrode actuation system 100.

With respect to FIGS. 1 and 3, the electrode actuation system 100 mayinclude a primary actuation member 112 and first and second sleeveactuation members 114, 116. The primary actuation member 112 may extendproximally from the handle 34 and may include an actuation shaft 118 anda knob 120 coupled to a proximal end of the actuation shaft 118. Theactuation shaft 118 may be tubular and may be fixedly coupled to thetubular sleeve 44 disposed within the primary lumen 42 of the treatmentcatheter 20. Upon moving the engaging switch 98 to the open position,the primary actuation member 112 may be moved proximally and distally toactuate the tubular sleeve 44 and the first and second sleeves 48, 50 incorresponding proximal and distal directions relative to the treatmentcatheter 20. Further, the primary actuation member 112 may be rotated,via the knob 120, to translate common or simultaneous rotationalmovement of each of the tubular sleeve 44 and the first and secondsleeves 48, 50. Further description as to the purpose and functionalityof the primary actuation member 112 will be discussed hereafter.

The first and second sleeve actuation members 114, 116 may extendproximally from the knob 120 of the primary actuation member 112. Eachof the first and second sleeve actuation members 114, 116 may includerespective first and second tubular members 122, 124 and respectivefirst and second knobs 126, 128 coupled to respective proximal ends ofthe first and second tubular members 122, 124. Further, the first andsecond sleeve actuation members 114, 116 may correspond with the firstand second sleeves 48, 50 and their respective first and secondelectrodes 52, 54. Upon moving the engaging switch 98 to the openposition (or any additional corresponding engaging switch), the firstand second sleeve actuation members 114, 116 may be independently movedlinearly in proximal and distal directions to translate correspondingindependent linear movement to the first and second sleeves 48, 50disposed in the treatment catheter 20. Such linear movement of the firstand second sleeves 48, 50 may be relative to the tubular sleeve 44and/or the treatment catheter 20. Further, the first and second knobs126, 128 of the respective first and second sleeve actuation members114, 116 may be independently rotated to translate independentrotational movement (clockwise or counter clockwise) of the respectivefirst and second electrodes 52, 54. Such rotational movement of thefirst and second electrodes 52, 54 may be relative to the first andsecond sleeves 48, 50. Furthermore, the first and second knobs 126, 128may each include a switch (not shown) to effect independent linearmovement (distally and proximally) of the respective first and secondelectrodes 52, 54 relative to the first and second sleeves 48, 50. Inthis manner, the first and second electrodes 52, 54 may be independentlycontrolled with rotational and linear movement.

Now with reference to FIG. 3, the first and second electrodes 52, 54 mayeach include a helical configuration 130 at a distal end portionthereof. Further, each helical electrode may include a pointed distalend 132. The first and second electrodes 52, 54 may be configured tocontact and extend into tissue of the valve. With the helicalconfiguration of the first and second electrodes 52, 54, the rotationalmovement (as indicated by dual rotational arrow 134) transferred to thefirst and second electrodes 52, 54 via the first and second knobs 126,128 at the handle 34 (see FIG. 1), facilitates the first and secondelectrodes 52, 54 to twist or sink into the tissue of a valve and besecured thereto. Likewise, rotational movement (in the oppositedirection) of the first and second electrodes 52, 54 readily facilitateswithdrawing the helical configuration of the first and second electrodes52, 54 from the tissue of the valve. Further, such pointed distal end132 of each of the helical electrodes may facilitate ready insertioninto the tissue.

Referring to FIG. 3A, in another embodiment, the first and secondelectrodes 52 a, 54 a may include a needle configuration 136 with apointed distal end 138. In other words, the needle configuration 136 ofthe distal portion of the first and second electrodes 52 a, 54 a extendsin a substantially linear manner relative to the orientation of thefirst and second sleeves 48, 50. With this arrangement, insertion of thefirst and second electrodes 52 a, 54 a into tissue may be employed withlinear movement translated from the first and second sleeve actuationmembers 114, 116 at the handle 34 (see FIG. 1). Further, the first andsecond electrodes 52 a, 54 a may be linearly moveable relative to thefirst and second sleeves 48, 50 such that the functionality of the firstand second sleeves 48, 50, as well as the tubular sleeve 44, may besubstantially similar to the previous embodiment. In still anotherembodiment, the first and second electrodes 52, 54 may include a limitedhelical configuration with only, for example, a half or up to one turnin the helical configuration. In another embodiment, rather than theneedle configuration 136, the first and second electrodes may include anatraumatic surface with, for example, a blunt end such that the firstand second electrodes are configured to make contact with the tissue atthe valve, but do not puncture (or go into) the tissue of the valve.

In another embodiment, similar to the embodiments of FIGS. 3 and 3A, thefirst and second sleeve members 48, 50 may each house and include aneedle portion and a loop portion. The needle portion may be extendablethrough an axis of the loop portion. The loop portion may include one ormore loops or spirals that may be spaced from and extend around theneedle portion. In one embodiment, the loop portion may include ahelical structure with spirals that radially taper toward the distal endor, otherwise said, the radius of the loops or spirals decrease towardthe distal end so as to have a tapered profile toward the distal end. Inone embodiment, the loop portion may be an electrode and the needleportion may be a temperature sensor. In this manner, the needle portionmay be linearly moved and positioned within the tissue to sense atemperature of the tissue with the loop portion making contact with theouter surface of the tissue to, thereby, receive RF energy and heat thetissue. Further, with this arrangement, the loop portion may contact alarger surface area of the tissue, than the electrodes described in theother embodiments herein, for heating the tissue with the needle portionpositioned in the tissue and sensing the temperature of the heatedtissue. In this embodiment, the needle portion and loop portion may beseparate distinct elements such that they are independently linearlymoveable relative to each other. In another embodiment, the needleportion and loop portion may be coupled together (or operatively coupledtogether along the length of first and second sleeves or handle) so thatthe needle portion and loop portion linearly move together, but areindependently linearly moveable relative to the other one of theelectrodes of the splayed first and second sleeves 48, 50.

With respect to FIG. 3B, in another embodiment, the treatment cathetersystem 12 may be configured to operate in a unipolar mode, similar tothat previously set forth and described relative to FIG. 2A. Forexample, the treatment catheter 20 may include at least one electrode220 having a first needle portion 222 and a second needle portion 224with a conductive element 226, such as a conductive coil, extendingtherebetween. The first and second needle portions 222, 224 of the atleast one electrode 220 may include similar functionality as thatdescribed in other embodiments herein, e.g., independent linear movementrelative to the first and second sleeves 48, 50. Likewise, the first andsecond sleeves 48, 50 as well as the tubular sleeve 44 may includesimilar functionality as that described in the other embodiments herein.With this arrangement, the unipolar mode of an electrode system may beemployed with the treatment catheter system 12. Further, in thisembodiment, the first and second sleeves 48, 50 may each include atemperature sensor (not shown) associated with its respective sleeveand/or associated with the first needle portion 222 and the secondneedle portion 224 so as to sense and provide the temperature of thetissue being heated by the at least one electrode 220.

Referring back to FIG. 3, as previously set forth, the first and secondelectrodes 52, 54 may be electrically isolated within lumens extendingalong the length of the first and second sleeves 48, 50 disposed withinthe treatment catheter 20. Further, the first and second sleeves 48, 50and their respective first and second electrodes 52, 54 may beindependently moved relative to each other, as indicated with first andsecond bi-directional arrows 146, 148. In other words, the first andsecond sleeve 48, 50 may be moved independently, distally or proximally,relative to the tubular sleeve 44 and/or the treatment catheter 20.

In another embodiment, the distal portion of the first and secondsleeves 48, 50 may be moved simultaneously between a constricted orconstrained position and one or more exposed or expanded positions withmovement of the tubular sleeve 44 relative to the first and secondsleeves 48, 50, as indicated by bi-directional arrow 152. In theconstricted position, the distal portion of each of the first and secondsleeves 48, 50 extend substantially linear or substantially parallel toeach other as they are positioned within the tubular sleeve lumen 46 ofthe tubular sleeve 44. In the exposed position, the first and secondsleeves 48, 50 are deployed from the tubular sleeve 44 and/or thetreatment catheter 20. In one embodiment, the first and second sleeves48, 50 may be biased away from each other, as indicated by arrow 150, soas to splay laterally outward. Such splayed condition of the first andsecond sleeves 48, 50 may be such that the distal portion of the firstand second sleeves 48, 50 maintain a substantially planar position inboth the constricted and exposed or expanded positions. Further, suchdistal portion of the first and second sleeves 48, 50 may extend fromthe tubular sleeve 44 in a v-configuration 140, or Y-configuration, orthe like.

In one embodiment, the first and second sleeves 48, 50 may each includeone or more rods (not shown) embedded in the wall of the first andsecond sleeves 48, 50 or, alternatively, adhesively attached to a wallsurface of the first and second sleeves 48, 50. In a relaxed state, theone or more rods may include a bend or curvature and be positioned onthe first and second sleeves 48, 50 such that, when in the constrictedposition, the first and second sleeves are biased laterally outward and,when in the exposed position, the first and second sleeves 48, 50 splaylaterally away from each other. With this arrangement, the distalportion of the first and second sleeves 48, 50 may be biased away fromeach other.

Further, in another embodiment, a lateral distance 142 between distalends of the first and second sleeves 48, 50 may be calculated anddetermined relative to a length 144 by which the distal end of thetubular sleeve 44 is withdrawn from the distal ends of the first andsecond sleeves 48, 50. That is, the lateral distance 142 between thedistal ends of the first and second sleeves 48, 50 is a function of ordependent upon the length 144 by which the tubular sleeve 44 iswithdrawn. In this manner, the lateral distance 142 between theelectrodes may be predetermined and further, may be enlarged orminimized to multiple predefined or predetermined lateral distances 142.The advantages for a physician to vary the lateral distance 142 betweenthe splayed distal ends of the first and second sleeves 48, 50 will beunderstood in view of the disclosure provided herein relative to heatingtissue regions of the valve.

As previously set forth, the distal end portion of the treatmentcatheter system 12 may include one or more temperature sensors. In oneembodiment, each of the first electrode 52 and the second electrode 54may include a temperature sensor 56 associated therewith. For example,the temperature sensor 56 may be positioned at a base (or proximal) ofthe helical configuration of each of the first and second electrodes 52,54. In another embodiment, the temperature sensor may be positioned at adistal end of each of the first and second sleeves 48, 50. In anotherembodiment, the temperature sensor 56 may be associated with the helicalstructure of the electrode itself. The temperature sensor 56 positionedadjacent to the first and second electrodes 52, 54 may be coupled to thecontroller 18 via respective electronic elements 58, 59, such as wires(see FIG. 1).

With respect to FIG. 3C, in another embodiment, a temperature sensor 230may be disposed within and moveable to extend from a third sleeve 232.The third sleeve 232 may be positioned between the splayed first andsecond sleeves 48, 50 that house the first and second electrodes 52, 54.The temperature sensor 230 associated with the third sleeve may be inaddition to (or instead of) the temperature sensors 56 (FIG. 3)associated with the first and second sleeves 48, 50.

The third sleeve 232 may be independently moveable in a linear direction(distally and proximally) relative to the first and second sleeves 48,50 and/or the tubular sleeve 44. Further, the temperature sensor 230 maybe independently linearly moveable relative to the third sleeve 232.Furthermore, the temperature sensor 230 may be associated with orinclude a helical structure 234 that may be rotated to twist into tissuebetween the first and second electrodes 52, 54. In this manner, thetemperature sensor 230 may sense the temperature of the tissue beingheated between the first and second electrodes 52, 54 and transmit suchtemperature to the controller 18 to control the RF energy being appliedto the tissue, similar to that depicted and discussed relative to FIGS.1 and 3. Further, the handle of the embodiment depicted in FIG. 3C mayinclude a third sleeve actuator member (not shown) similar to the firstand second sleeve actuator members 114, 116 depicted in FIG. 1 so as tofacilitate linear and rotational movement of the third sleeve 232 andthe temperature sensor 230. Furthermore, as can be appreciated, suchthird sleeve actuator member may include an electronic element (notshown) coupling the temperature sensor 230 to the controller 18.

In another embodiment, the temperature sensor 230 extending from thethird sleeve 232 may be associated with or include a needleconfiguration. In another embodiment, the temperature sensor 230extending from the third sleeve 232 may be associated with or include aflat surface that is atraumatic and sized and configured to contact theouter surface of the tissue between the first and second electrodes 52,54 to sense the temperature thereof. The temperature sensors disclosedherein may be any suitable type of temperature sensor known to one ofordinary skill in the art, such as a thermocouple or thermistor.

In another embodiment, the third sleeve 232 may be sized and configuredto house a third electrode similar to the first and second sleeves 48,50 and their respective first and second electrodes 52, 54 such that thethird electrode may include the helical structure as depicted in FIG.3C. Further, in this embodiment, the third sleeve may include atemperature sensor associated therewith or the temperature sensor may beassociated with the electrode itself similar to the previousembodiments. In this embodiment, the handle 34 would include anassociated third sleeve actuator member similar to the first and secondsleeve actuator members 114, 116 and lines or conductive elementsextending to the controller 18 as well as the RF energy source 16,similar to that depicted in FIG. 1.

With respect to FIGS. 1 and 3, generally, medical grade metals, metalalloys, plastics, polymers, synthetics may be used to fabricate themedical device system 10 including the sheath 14, the treatment cathetersystem 12, and its associated electrode components. As known to one ofordinary skill in the art, the sheath 14 and treatment catheter 20 withits respective tubular sleeve 44, and first and second sleeves 48, 50may be formed from a polymeric material, such as,polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP),high-density polyethylene (HDPE), polyether block amide (PEBA), nylon,polyimide, polyamide, or any other suitable polymeric material, as wellas may include metallic/polymeric coils, braids, and various sealingrings, and metallic components and fasteners for coupling the variouscomponents of the medical device system 10. Such components may beformed using various manufacturing techniques, such as extrusion,thermal reflowing, braiding, etc., or any other manufacturing techniqueas known by one of ordinary skill in the art. The electrodes 52, 54 maybe made of a metallic material, such as stainless steel, platinumiridium, mp35, mp35 n-lt, silver, tungsten, tantalum, drawn filledtubing (DFT) or combinations thereof, as known in the art. The handle 34and its various components may be formed of plastic and metallicmaterials, various sealing rings, fasteners, etc., that may be machinedor formed with various molding techniques, as known to one of ordinaryskill in the art.

With respect to FIGS. 4 through 10, implementation of the medical devicesystem, according to one embodiment, will now be described relative to,for example, the mitral valve 170 in the heart 160. As previously setforth, the medical device system of the present invention is generallyconfigured to non-invasively and percutaneously treat valves to minimizeand/or prevent valve regurgitation or valve prolapse and may beimplemented with any of the valves in the heart.

FIG. 4 is a general representation of the heart 160 and its circulatorysystem, depicting the four chambers of the heart, namely, the rightatrium 162 and the right ventricle 164 with the tricuspid valve 166therebetween and the left atrium 168 and the left ventricle 172 with themitral valve 170 therebetween. In this example, the valve to be treatedis the mitral valve 170. As such, access to the left atrium 168 may beemployed using known techniques and procedures by a physician, such asperforming a trans-septal puncture at the septum wall 178 between theright and left atria 162, 168. The physician may then advance the sheath14 of the medial device system 10 over a wire (not shown) through theinferior vena cava 174 and then through the septum wall 178 to gainaccess to the left atrium 168. Once the distal portion of the sheath 14is positioned in the left atrium 168, the imaging member 80 may beadvanced through the sheath lumen 26 and deployed in the left atrium168, FIG. 4 depicting the imaging loop 80 partially deployed in the leftatrium 168 adjacently above the mitral valve 170. The physician mayutilize imaging techniques to view the mitral valve 170 with, forexample, flushing contrast into the left atrium 168 such that thephysician can position the distal end of the sheath 14 adjacent themitral valve 170 to fully deploy the imaging member 80 within the mitralvalve 170.

FIGS. 5 and 5A depict the imaging member 80 fully deployed in the mitralvalve 170, FIG. 5 depicting a simplified side view of the left atrium168 and left ventricle 172 of the heart 160. Upon deploying the imagingmember 80 within the mitral valve 170, the imaging member 80 mayself-orient at corners 184 between the posterior annulus and theanterior annulus 182 of the valve 170. Once the imaging member 80self-orients within the valve with the head portion 82 of the imagingmember 80 disposed in the left ventricle 172, if the imaging member 80has not self-seated, the physician may move the imaging member 80distally to seat the shoulder portions 84, 86 against the outer edge 186of the valve 170. With the imaging member 80 in the seated and orientedpositions, the head portion 82 of the imaging member 80 extends into theleft ventricle 172 with the first and second shoulder portions 84, 86extending laterally from the corners 184 and over the outer edge 186 ofthe valve 170. FIG. 5A is a top view of the mitral valve 170 (viewedfrom the left atrium 168), depicting a simplified partial view of thefirst and second shoulder portions 84, 86 of the imaging member 80extending laterally and resting over the outer edges 186 of the valve170 between the posterior annulus 180 and the anterior annulus 182 ofthe mitral valve 170. The mitral valve 170, depicted in FIG. 5A,illustrates an example of an unhealthy enlarged mitral valve undergoingregurgitation, depicting the mitral valve 170 with a gap 188 between theposterior and anterior leaflets 183, 185 when it should be in a fullyclosed position.

Now with reference to FIG. 6, upon the imaging member 80 beingpositioned in the mitral valve 170, the physician may obtain imaginginformation relative to the radiopaque markers 92 (FIG. 3) or coatingassociated with the imaging member 80 as well as by injecting contrastthrough the sheath or treatment catheter 20. Such imaging informationmay include various dimensions of the mitral valve 170, such asdimensions relative to the posterior annulus 180 and the posteriorleaflet 183, and the anterior annulus 182 and the anterior leaflet 185,and any other features/dimension that may be ascertained and useful. Inthis example, the tissue of the valve to be treated is the posteriorannulus 180, depicted between dashed boundary line 187 and the outeredge 186 extending between the first and second shoulder portions 84, 86of the imaging member 80. Based on the imaging information anddimensions obtained therefrom, the physician may determine regions withassociated boundaries for heating the posterior annulus 180.

For example, the posterior annulus 180 may be divided into four regions,namely, a first tissue region 190, a second tissue region 192, a thirdtissue region 194, and a fourth tissue region 196 each associated withrespective boundary lines, namely, a first boundary line 200, a secondboundary line 202, a third boundary line 204, a fourth boundary line206, and a fifth boundary line 208. Such division of regions of theposterior annulus 180 will be for purposes of heating the tissue withthe electrodes of the treatment catheter 20 attached or positionedgenerally along the associated boundary lines, as discussed in furtherdetail herein. Along each boundary line associated with one or tworegions of the posterior annulus 180, each boundary line may alsoinclude an associated target point (or otherwise said, a target area) atwhich the physician may target contacting the posterior annulus 180 withone of the first and second electrodes, namely, a first target point210, a second target point 212, a third target point 214, a fourthtarget point 216, and a fifth target point 218. Depending on thedimensions of the posterior annulus 180 and other factors, such as thegap 188 of an unhealthy valve, the physician may divide the posteriorannulus 180 into two or three regions or even up to five or six regions.Further factors relating to dimensioning and the number of regions to betreated may take into account the viable minimum and maximum predefinedlateral distances 142 between the splayed distal ends of the first andsecond electrodes 52, 54 that may be readily employed relative to thedimensions of the given posterior annulus 180, as previously describedrelative to FIG. 3.

With respect to FIGS. 1 and 6, once the physician has obtained thedesired imaging information, the physician may then advance thetreatment catheter toward the first target point 210 or along the firstboundary line 200 determined on the posterior annulus 180 and adjacentthe first shoulder portion 84 of the imaging member 80. In addition, toassist the physician, the steering actuator 96 may be actuated to orientthe distal portion of the treatment catheter 20 so as to point thedistal end toward the first shoulder portion 84 of the imaging member80.

With respect to FIGS. 1 and 6A, in one embodiment, the first sleeve 48may be moved distally relative to the tubular sleeve 44 by linearlyactuating the first sleeve actuation member 114 at the handle 34 tocontact the first target point 210 on the posterior annulus 180 adjacentthe first shoulder portion 84 of the imaging member 80. At this stage,the second sleeve 50 may be maintained within the tubular sleeve 44.With reference to FIGS. 1 and 6B, upon contacting the posterior annulus180 at the first target point 210, the first electrode 52 may beextended into and secured to the posterior annulus 180 by rotationallyactuating the first knob 126 of the first sleeve actuation member 114 atthe handle 34. Similarly, the second sleeve 54 may then be moveddistally by linearly moving the second sleeve actuation member 116 atthe handle 34 to contact the second target point 212 on the posteriorannulus 180, after which, the second electrode 54 may be moved distallyby rotating the second knob 128 at the handle 34.

With continued reference to FIGS. 1 and 6B, in another embodiment, boththe first and second sleeves 48, 50 may be simultaneously exposed ormoved distally relative to the tubular sleeve 44 by, for example,actuating the primary actuation member 112 at the handle 34. Such may beemployed by moving the primary actuation member 112 proximally towithdraw the tubular sleeve 44 and, thereby, expose both the first andsecond sleeves 48, 50. As previously set forth, the first sleeve 48 maythen be positioned over the first target point 210 and then attached tothe posterior annulus 180 with the first electrode 52. Similarly, thesecond sleeve 50 may then be positioned and attached to the posteriorannulus 180 at the second target point 212. Further, the attachment ofthe first and second electrodes 52, 54 to the posterior annulus 180 mayreadily be employed due to the helical configuration of the electrodessuch that the electrodes may be rotated via the first and second knobs126, 128 at the handle 34 to secure the first and second electrodes 52,54 into the tissue of the posterior annulus 180. As such, the first andsecond sleeves 48, 50 may be individually deployed for contacting andsecuring to the posterior annulus 180 as well as the first and secondsleeves 48, 50 may be simultaneously deployed from the tubular sleeve 44for securing to the posterior annulus 180.

Now with reference to FIGS. 1, 6B, and 7, upon contacting or securingthe first and second electrodes 52, 54 to the posterior annulus 180 atthe respective first and second target points 210, 212, as depicted inFIGS. 6B and 7, the tissue between the first and second electrodes 52,54 or a first tissue region 190 can be heated by activating the firstand second electrodes 52, 54. Such heating of the tissue may be employedat predetermined RF energy levels and for a predetermined period oftime. In one embodiment, the RF energy level may be modulated in therange of about 0 to 100 watts and for a period of time ranging betweenabout twenty seconds to five minutes until the tissue is heated to atemperature in the range of approximately 50 degrees to 85 degreesCelsius. As previously set forth, the first and second electrodes 52, 54may be activated by transmitting RF energy from the RF energy source 16or RF generator, the RF energy source 16 being electrically coupled tothe first and second electrodes 52, 54. Further, as previously setforth, the one or more temperature sensors (not shown) may transmittemperature readings of the tissue being heated to the controller 18.Once the tissue has been heated sufficiently, the controller 18 mayautomatically de-activate or reduce the RF energy source 16. Inaddition, or instead of, there may be a display for the physician toview the temperature reading so that the physician may manuallyde-activate the RF energy source 16 once the tissue region issufficiently heated. With this arrangement, the tissue may be heated toensure sufficient heating of the tissue as well as to minimize overheating the tissue at the valve 170. Such activation and de-activationof the RF energy source 16 may be at a switch on the housing of the RFenergy source or at a foot pedal coupled to the RF energy source 16 oron the handle 34 of the treatment catheter system 12.

With respect to FIGS. 1 and 7A, upon treating the tissue at the firsttissue region 190 with RF energy, the first electrode may be withdrawnfrom the tissue and into the first sleeve 48 by rotating the first knob126 of the first sleeve actuation member 114 at the handle 34. The firstsleeve 48 may now be moved from the first target point 210 to the thirdtarget point 214 defined along the third boundary line 204 (FIG. 6)defined on the posterior annulus 180 to treat a second tissue region192. Movement of the first sleeve 48 to the third target point 214 maybe employed by rotating the tubular sleeve 44 about 180 degrees, asindicated by rotational arrow 220, by rotating the knob 120 of theprimary actuation member 112 at the handle 34 while the second electrode54 maintains its secured position at the second target point 212 on theposterior annulus 180. With this arrangement, the tubular sleeve 44 andthe first and second sleeves 48, 50 rotate and, more particularly, pivotabout the second sleeve 50 with the second electrode 54 maintaining itsposition in the tissue. Once the tubular sleeve 44 and first and secondsleeves 48, 50 are pivoted with the first sleeve 48 positioned at thethird target point 214 (as depicted in outline form in FIG. 7A), thefirst electrode 52 may be secured to the tissue of the posterior annulus180 at the third target point 214 by rotating the first knob 126 todistally extend the first electrode 52 into the tissue. In oneembodiment, the primary actuator member 112 may be rotated to rotate thetubular sleeve 44 as well as the first and second sleeves 48, 50 in aclockwise and counter-clockwise direction with free rotation. In anotherembodiment, the primary actuator member 112 may include a mechanism tolimit or control the amount of rotation of the tubular sleeve 44 and thefirst and second sleeves 48, 50. For example, the mechanism forcontrolling such rotation may be limited to a full turn or angle ofrotation of 360 degrees in both the clockwise and counter-clockwisedirections. In another embodiment, the mechanism for controlling suchrotation may be limited to the range of 110 to 250 degrees and, further,within the range of 135 degrees and 225 degrees in both the clockwiseand counter-clockwise directions.

Now with reference to FIGS. 8, 9, and 10, similar steps may be employedto that previously described to heat the remaining tissue regions. Forexample, as depicted in FIG. 8, the first and second electrodes 52, 54are secured to the tissue of the posterior annulus 180 with a secondtissue region 192 therebetween. As such, the tissue of the second tissueregion 192 may then be heated with RF energy, similar to that previouslyset forth for the first tissue region 190. With respect to FIGS. 8 and9, once the second tissue region 192 has been sufficiently heated, thesecond electrode 54 may be withdrawn from the tissue so that the tubularsleeve 44 (as well as the first and second sleeves 48, 50) may rotate topivot about the first sleeve 48 with the first electrode 52 maintainingits position in the tissue. The pivoted second sleeve 50 may then bepositioned at the fourth target point 216 along the fourth boundary line206 (similar to the process described and depicted in FIG. 7A). Thesecond electrode 54 may then be rotated and secured to the fourth targetpoint 216. As such, once the tubular sleeve 44 is pivoted and the secondelectrode 54 secured to the tissue proximate the fourth boundary line206 at the fourth target point 216, as depicted in FIG. 9, the tissuebetween the first and second electrodes 52, 54 may be heated to treatthe third tissue region 194. With respect to FIGS. 9 and 10, once thethird tissue region 194 has undergone heat treatment, the firstelectrode 52 may be withdrawn from proximate the third boundary line 204so that the tubular member 44 may be rotated to move the first sleeve 48to the fifth boundary line 208 so as to pivot about the second sleeve50, similar to that previously described. The first electrode 52 maythen be secured proximate to the fifth boundary line 208 so that thetissue in the fourth tissue region 196 may be heat treated, as depictedin FIG. 10.

With respect to FIGS. 10 and 11, once the fourth tissue region 196 hasbeen treated with RF energy, the first and second electrodes 52, 54 maybe withdrawn from the tissue and into the respective first and secondsleeves 48, 50 and the tubular sleeve 44 may be moved proximally intothe treatment catheter 20. The physician may now view the mitral valveand assess whether there has been ample tissue shrinkage so as torestore the valve to proper function. Due to the high collagen contentof the tissue at the mitral valve 170, the tissue shrinking effects arealmost immediate and, thus, the physician may determine whether theprocedure was successful or if additional tissue regions for heatingshould be implemented. Once the physician is satisfied that the valvehas been restored to healthy valve function, the physician may thenwithdraw and remove the treatment catheter 20, imaging member 80, andsheath 14 from the heart and vascular system of the patient.

Advantageously, the denatured collagen in the tissue resulting fromheating the tissue with RF energy is absorbed and replaced with newcollagen over a minimal period of time. As such, if in the future thevalve digresses and the mitral regurgitation condition returns, thephysician can readily again perform the same procedure set forth hereinto treat the valve with RF energy to, thereby, modify the geometry ofthe mitral valve and again restore proper function to the valve.

Now referring to FIGS. 12, 12A, 13 and 14, another embodiment of amedical device system 240 for treating a valve is provided. With respectto FIGS. 1, 12 and 12A, the medical device system 240 of this embodimentmay include the sheath 14, the imaging member 80, the treatment catheter20 and handle 34. Rather than the first and second sleeves and theassociated first and second electrodes previously described, thisembodiment may include a treatment device 250 disposed at the distal end36 of the treatment catheter 20. Such a treatment device 250 may includeexposed electrode portions 252 of one or more electrodes 256 disposedand positioned on at least a lower periphery of the treatment device 250with markers 258 associated with each of the exposed electrode portions252.

Referring now to FIGS. 12 and 12A, the treatment device 250 may be movedbetween a constricted position and an expanded position. In theconstricted position, the treatment device 250 may be disposed withinthe treatment catheter 20 and, upon the treatment device 250 being movedrelative to the distal end 36 of the treatment catheter 20, thetreatment device may be deployed. Such movement of the treatment device250 may be employed by either moving the treatment catheter 20proximally relative to the treatment device 250 or the treatment device250 may be moved distally to move the treatment device 250 relative tothe distal end 36 of the treatment catheter 20. In this manner, thetreatment device 250 may be deployed to radially self-expand to theexpanded position.

In the expanded position, the treatment device 250 may exhibit abasket-like configuration formed of a weaved structure 260 with multiplestrands 262. Such multiple strands 262 may include a super-elasticmaterial, such as Nitinol wires, that may be insulated with a polymerformed thereon. The treatment device 250 may define an axis 264extending co-axially or parallel with the treatment catheter 20 suchthat the treatment device 250 may be configured to radially expand fromand relative to the axis 264. Such weaved structure 260 may includevarious configurations to radially expand and conform to a valveannulus. For example, the treatment device 250 may include a proximalside 266 and a distal side 268, the proximal side 266 radially extendingwith a generally convex periphery and the distal side including a lip270 and pad portion 272 extending along a lower or distal periphery ofthe treatment device 250. The distal side 268 may also define a concaveportion 274 extending along the periphery of the distal side 268.Further, the treatment device 250, in a fully expanded position, mayinclude a substantially circular profile to exhibit an arcuate structurealong the periphery (viewing the device from the proximal or distalsides). However, the weaved structure 260 of the treatment device 250allows for the profile or lip 270 of the treatment device 250 to conformto the size of the annulus of the valve. In this manner, the profile ofthe treatment device 250 may conform to an oval or kidney-bean shape, orany other valve shape. For example, FIG. 14 depicts a simplified view ofthe treatment device 250 in the expanded position positioned over amitral valve 170, depicting a profile of the treatment device 250conforming to a tissue shelf 179 (see also FIG. 13) of the annulus 177of the mitral valve 170 with the one or more electrodes 256 in contactwith the valve annulus.

With respect to FIGS. 12 and 14, as set forth above, the lower peripheryor pad portion 272 of the treatment device 250 may include multipleexposed electrode portions 252 of one or more electrodes 256. Suchexposed electrode portions 252 may be spaced along the pad portion 272of the treatment device 270 and adjacent an edge or lip 270 between theproximal side 266 and distal side 268 of the treatment device 250. Eachof the exposed electrode portions 252 may include a conductive line 276extending therefrom. Each of the conductive lines 276 may extend throughthe lumen of the treatment catheter 20 and to the RF energy source 16(FIG. 1). With this arrangement, a physician may selectively activateparticular ones of the exposed electrode portions 252 for treatingselective portions of the annulus 177, described in further detailherein. The selected exposed electrode portions 252 may act as a singleelectrode or operate as multiple electrodes. Further, the treatmentdevice 250 of this embodiment may operate in at least one of unipolarmode and bipolar mode, similar to that set forth and described relativeto FIGS. 2A and 2B.

To assist the physician in selectively activating particular ones of theexposed electrode portions 252, each of the exposed electrode portions252 may include a marker 258 associated therewith. In one embodiment,the exposed electrode portions 252 themselves may be formed of aconductive and a highly dense radiopaque material to act as the marker.In another embodiment, the markers 258 may be positioned and formedimmediately adjacent each of the exposed electrode portions 252.Further, in another embodiment, one exposed electrode portion mayinclude a reference marker (not shown) distinct from the other markersassociated with the exposed electrode portions 252 in order to properlyselect particular ones of the exposed electrode portions. In anotherembodiment, a portion of the treatment device 250 may include areference marker so that a physician can readily determine and selectwhich exposed electrode portions to activate.

Further, as set forth in previous embodiments, the treatment device 250may include one or more temperature sensors 280. The one or moretemperature sensors 280 may be positioned along the pad portion 272 oradjacent to the lip 270 of the treatment device 250 and may be sized andconfigured to sense a temperature of the tissue being treated. Such oneor more temperature sensors 280 may be coupled to the controller and RFenergy source to assist a physician in treating the tissue of the valvewithin a temperature range, as previously set forth herein (see FIG. 1).

Now with primary reference to FIGS. 13, 14, and 15, a method fortreating the annulus 177 of a valve, such as a mitral valve 170, withthe treatment device 250 will be described. It should be noted that thetreatment device 250 is not limited to being employed with the mitralvalve 170, but may be implemented with other valves in, for example, theheart.

As set forth in step 282, a physician may advance the distal end 24 ofthe sheath 14 through the vascular system so that the distal end 36 ofthe sheath is positioned adjacent a valve in a heart (similar to thatpreviously described in reference to FIGS. 4 and 5) so that the imagingmember 80 may be advanced through the sheath 14 and positioned withinthe valve and provide orientation information to the physician relativeto the valve. As set forth in step 284, the physician may then advancethe distal end 36 of the treatment catheter 20 through the sheath 14 tocenter and position the distal end 36 of the treatment catheter 20adjacent to and above the mitral valve 170. Upon positioning the distalend 36 of the treatment catheter 20, the treatment device 250 may bedeployed from the treatment catheter 20. FIG. 13 depicts the treatmentdevice 250 partially deployed from the treatment catheter 20 in asubstantially centered position above the mitral valve 170. As thetreatment device 250 is being deployed, the treatment device 250radially expands and conforms to (or nests with) the tissue shelf 179defining the annulus 177 of the mitral valve 170. In this manner, as setforth in step 286, the physician may position the treatment device 250over the mitral valve 170 such that the exposed electrode portions 252of the one or more electrodes 256 contact tissue of the valve annulus177, as depicted in FIG. 14. The physician may then view the imagingmember 80 and the markers 258 associated with each of the exposedelectrode portions 252, as indicated in step 288. As in previousembodiments, typical imaging techniques may be employed as known to oneof ordinary skill in the art. Such imaging techniques allow thephysician to readily determine the posterior portion 180 (or posteriorannulus) of the valve annulus 177 since the first and second shoulderportions 84, 86 of the imaging member 80 define and separate theposterior and anterior portions 180, 182 of the valve annulus 177.Further, the physician may then determine which exposed electrodeportions 252 of the treatment device 250 are positioned over theposterior annulus 180 and are between the first and second shoulderportions 84, 86 of the imaging member 80 via the markers 258 associatedwith each of the exposed electrode portions 252. In this manner, asindicated in step 290, the physician may selectively activate theparticular exposed electrode portions 252 positioned between the firstand second shoulder portions 84, 86 of the imaging member 180 that arepositioned over the posterior portion 180 of the valve annulus 177.

With respect to FIGS. 1 and 14, as in previous embodiments, the one ormore electrodes 256 are operatively coupled to the RF energy source 16and may be activated by the physician from the RF energy source toprovide RF energy to the one or more electrodes 256 of the treatmentdevice 250 to treat the desired tissue of the valve annulus 177. The RFenergy source 16 may include input controls (not shown) to distinguishand activate the particular exposed electrode portions 252 selected bythe physician. Further, as in previous embodiments, the treatment device250 may include one or more temperature sensors 280 operatively coupledto the controller 18 and the RF energy source 16. As such, as the tissueis receiving RF energy, the one or more temperature sensors 280 maysense the tissue temperature and automatically control the RF energysource 16 once the desired temperature of the tissue has been reached sothat the tissue is not over heated.

Now with reference to FIGS. 16 and 16A, another embodiment of atreatment device 300 is provided. In this embodiment, the treatmentdevice 300 may be in the form of an expandable loop or expandablearcuate portion. The treatment device 300 may include an elongatestructure 302 having a first elongate portion 304 and a second elongateportion 306. The elongate structure 302 may be conformable and flexibleso as to facilitate the elongate structure 302 to be moved between aconstricted position and an exposed or expanded position. In theconstricted position, the first and second elongate portions 304, 306may be positioned alongside each other within the treatment catheter 20with a tight bend at the distal end 36 of the treatment catheter 20where the first and second elongated portions 304, 306 extend from eachother. In the exposed or expanded position, the elongate structure 302may be deployed from the distal end 36 of the treatment catheter 20 toexhibit a loop configuration or an arcuate configuration or structure.The loop configuration may be substantially similar to a shape of theparticular valve to be treated, such as a kidney-bean shape for themitral valve, and may be pre-disposed to form such shape.

As set forth, the elongate structure 302 may include the first andsecond elongate portions 304, 306. In one embodiment, the first elongateportion 304 may be configured to maintain a fixed linear positionrelative to the distal end 36 of the treatment catheter 20. In otherwords, the first elongate portion 304 may be fixed so as to not movedistally or proximally relative to the distal end 36 of the treatmentcatheter 20. The first elongate portion 304 may be at least partiallypositioned at a distal portion of the treatment catheter 20 and may onlybe slightly exposed at the distal end 36. With the first elongateportion 304 fixed, the second elongate portion 306 may be linearlymoveable distally and proximally, as shown with bi-directional arrow308, relative to the distal end 36 of the treatment catheter 20. Upondistal movement of the second elongate portion 306, the elongatestructure 302 of the treatment device 300 may be deployed and may expandto the loop configuration. Further, the size of the loop configurationmay be controlled by a length by which the second elongate portion 306is moved distally. As such, the treatment device 300 of this embodimentmay be sized in real-time to nest appropriately with the size of aparticular valve, such as the mitral valve. Further, the second elongateportion 306 may be sized and configured to self-expand to, for example,a kidney-bean shape or to the shape of the valve annulus that thetreatment device 300 is intended to treat. With this arrangement, thetreatment device 300 may be positioned within various sized valves. Inanother embodiment, the first and second elongate portions 304, 306 ofthe treatment device 300 may both move proximally and distally relativeto the distal end 36 of the treatment catheter 20.

In another embodiment, the elongate structure 302 of the treatmentdevice 300 may also include one or more stabilizing members 310. Suchone or more stabilizing members 310 may be sized and configured tofacilitate pulling and pushing of the elongate structure 302. Each ofthe one or more stabilizing members 310 may be coupled to a separatelocation of the elongate structure 302 and extend through the treatmentcatheter 20 to the handle (not shown) so as to facilitate control ofpulling or pushing the elongate structure 302 to stabilize the treatmentdevice 300 at the valve. In this manner, the physician may be able tooperate actuators or controls at the handle (not shown) to applypressure to the elongate structure or to assist the physician inobtaining optimal position of the elongate structure 302 over the valveannulus.

Each of the one or more stabilizing members 310 may include a line and acoil combination to facilitate pulling and pushing on the elongatestructure 302. The line may be coupled to a coupler 312, such as a latchor the like, positioned on the elongate structure 302 and extend throughthe coil. The line may be a wire made of stainless steel, Nitinol, apolymer or any other suitable wire structure. The coil may be formedwith one or more wires and may be woven and/or a helical structure. Thecoil may include a polymer wrap that may be attached with heat, forexample. With this arrangement, the line may facilitate pulling theelongate structure 302 to assist in positioning the elongate structure302 over the valve annulus and the coil may facilitate the pushing ofthe elongate structure 302 to assist in positioning and stabilizing theelongate structure over the valve annulus.

In addition, the treatment device 300 may include exposed electrodeportions 314 of one or more electrodes 316. The exposed electrodeportions 314 may be spaced along the elongate structure 302 of thetreatment device 300. In one embodiment, the exposed electrode portions314 may be positioned along the second elongate portion 306 of theelongate structure 302. As in the previous embodiment, the exposedelectrode portions 314 may operate as a single electrode or as multipleelectrodes. Further, each of the exposed electrode portions 314 mayinclude a marker 318 associated therewith. With this arrangement, aphysician may select particular electrode portions of the exposedelectrode portions 314 to be activated. Furthermore, the treatmentdevice 300 may include one or more temperature sensors (not shown) forsensing a temperature of the tissue being treated. Such one or moretemperature sensors may be operatively coupled to the controller 18 andRF energy source 16 (FIG. 1) to control and as a safe guard against theRF energy overheating the valve annulus, as previously set forth herein.In one embodiment, the one or more temperature sensors may be positionedadjacent to and between some or each of the exposed electrode portions314. In another embodiment, the one or more temperature sensors mayextend through, for example, the coil portion of the one or morestabilizing members 310 such that the temperature sensor may be linearlymoveable distally to the tissue to sense the temperature thereof.

Now with reference to FIGS. 17 and 18, description of positioning andtreating the valve annulus 177 with the expandable loop treatment device300 will now be provided. Prior to positioning the treatment device 300of this embodiment, the imaging member 80 may be positioned in the valvewith the first and second shoulder portions 84, 86 of the imaging member80 positioned over the valve annulus 177 to define the posterior andanterior portions 180, 182 of the annulus, as set forth in previousembodiments. The physician may then position the distal end 36 of thetreatment catheter 20 adjacent one of the shoulder portions, forexample, the second shoulder portion 86 in preparation for positioningthe treatment device 300 over a portion of the annulus, for example, theposterior portion 180 of the valve annulus 177. As in previousembodiments, the imaging member 80 includes various markers so that thephysician can readily determine the location for positioning the distalend 36 of the treatment catheter 20.

Once the distal end 36 of the treatment catheter 20 is positionedadjacent the second shoulder portion 86 of the imaging member 80, thephysician may distally move (as shown by directional arrow 326) thesecond elongate portion 306 of the treatment device 300 to begin formingand expanding the loop configuration, as depicted in FIG. 17. Bymaintaining the distal end 36 of the treatment catheter 20 adjacent thesecond shoulder portion 86 of the imaging member 80 and applyingpressure or slightly pushing on the one or more stabilizing members 310,the loop configuration of the treatment device 300 may be stabilized inthe valve annulus 177. If it is determined that a portion of the secondelongate portion 306 is not appropriately positioned, the physician maymanipulate the second elongate portion 306 by pulling the stabilizingmember 310 and then pushing the stabilizing member 310 into theappropriate position over the posterior portion 180 of the valve annulus177. If the treatment device 300 is completely moved from the annulus177, the physician may withdraw the second elongate portion 306proximally into the treatment catheter 20 and then deploy the treatmentdevice 300 again employing the method set forth above to obtain adesired position over the annulus 177.

As depicted in FIG. 18, upon positioning the loop configuration of thetreatment device 300 over the valve annulus 177, the physician mayreadily view the markers 318 associated with each of the exposedelectrode portions 314 as well as the first and second shoulder portions84, 86 of the imaging member 80 by employing known imaging techniques.As in the previous embodiment, the physician may then selectivelyactivate the exposed electrode portions 314 positioned between the firstand second shoulder portions 84, 86 of the imaging member 80 toselectively treat the posterior portion 180 of the valve annulus 177. Inthis manner, each of the method steps provided for in FIG. 15 anddescribed relative thereto are applicable in this embodiment fortreating the valve annulus 177, as will be readily understood by one ofordinary skill in the art.

FIGS. 19, 20, and 20A depict another embodiment of a treatment device340 disposed at the distal end 36 of the treatment catheter 20 of thepresent invention. In this embodiment, the treatment device 340 mayinclude an elongate structure 342 that may move between constricted andexpanded positions, the constricted position being disposed within thetreatment catheter 20 and/or sheath 14 (FIG. 1) and the expandedposition being deployed from the treatment catheter 20 or sheath 14. Theelongate structure 342 may include a treatment portion 344, an armportion 346 and a body portion 348. The treatment portion 344 mayself-expand to an arcuate configuration or structure and may beconfigured to self-expand or extend to, for example, a shape similar toa posterior portion of a valve annulus. The treatment portion 344 mayinclude a proximal end 352 and a distal free end 354, the proximal end352 extending from the arm portion 346. The arm portion 346 may extendat an upward angle toward the body portion 348 of the treatment device340. The body portion 348 may extend from the arm portion 346 and upwardthrough the lumen of the distal end 36 of the treatment catheter 20.Similar to the previous embodiment, the treatment device 340 may includeone or more stabilizing members 356, similar to the previous embodiment.At least one of the stabilizing members 356 may be coupled adjacent thedistal free end 354 of the treatment device 340 so as to control andstabilize the treatment portion 344 of the treatment device 340positioned over the valve annulus.

As in the previous embodiments, the treatment portion 344 may includeexposed electrode portions 360 of one or more electrodes 362 that may bespaced along the arcuate configuration of the treatment portion 344.Further, the treatment device 340 may include one or more temperaturesensors (not shown) operatively coupled to the controller 18 and RFenergy source 16 (FIG. 1) so as to control the heating of the tissue ofthe valve annulus. Such one or more temperature sensors may bepositioned between the exposed electrode portions 360 or may extendthrough the one or more stabilizing members 356. Furthermore, one ormore of the exposed electrode portions 360 may include a marker 361 forimaging purposes and selection of particular electrode portions 360 toactivate. As depicted in the cross-sectional view of the body portion348 of FIG. 20A, the body portion 348 may define a lumen 364 throughwhich multiple electrode lines 366 may extend. Each of such electrodelines 366 may correspond with one of the exposed electrode portions 360.Similar electrode lines 366 corresponding with the exposed electrodeportions 360 may be employed with the elongate structure 302 depicted inthe previous embodiment (see FIG. 16), as will be readily understood byone of ordinary skill in the art.

Now with reference to FIGS. 21 and 22, another embodiment of a treatmentdevice 380 disposed at the distal end 36 of the treatment catheter 20 isprovided. The treatment device 380 of this embodiment may include a bodyportion 382 extending to a ring structure 384 or arcuate structure. Thering structure 384 may include exposed electrode portions 386 of one ormore electrodes 388, as in the previous embodiments. Further, one ormore of the exposed electrode portions 386 may be associated with amarker 387. The ring structure 384 may be circular shaped, oval shaped,or kidney-bean shaped, or any other suitable ring structure. Thetreatment device 380 may include a stabilizing member 390, similar tothe previous embodiments. The body portion 382 may be bendable at adistal end 392 thereof such that, upon deploying the treatment device380, the stabilizing member 390 may be pulled to bend the ring structure384 to an orientation that corresponds with the valve annulus, asdepicted in FIG. 22. With this arrangement, upon positioning the ringstructure 384 over the annulus, the physician may view the markers 387associated with the exposed electrode portions 386 relative to the firstand second shoulder portions of the imaging member (not shown) andselect particular ones of the exposed electrode portions 386 to activateand treat a portion of the annulus, such as the posterior annulus,similar to that described and set forth in previous embodiments.Further, as in previous embodiments, in conjunction with the controller18, the treatment device 380 of this embodiment also may include one ormore temperature sensors (not shown) operatively coupled to thecontroller 18 and RF energy source 16 to sense the temperature of thetissue being treated to ensure such tissue is not overly heated (seeFIG. 1).

In another embodiment, the imaging member 80 set forth herein may beincorporated with the various embodiments of the treatment device. Forexample, the treatment device set forth in FIG. 12 may include animaging member incorporated therewith that may extend distally of thetreatment device with, for example, a U-shaped configuration, andself-orient within the valve. Another embodiment may include twoelongated imaging members with atraumatic tips, such as J-shaped tips,one at each opposing side of the treatment device that may extendthrough the valve structure and self-orient therein so that thephysician can readily determine a portion of the valve, such as theposterior annulus, to treat.

In another embodiment, the treatment device having an arcuate structure,similar to that shown in FIGS. 12, 16, 19, and 21, may include multipleimaging members coupled to and freely or loosely hanging from a distalside of the treatment device. For example, the treatment device mayinclude four to ten imaging members (or more) that freely hang distallyfrom the treatment device. Upon deploying the treatment deviceadjacently above the valve, the imaging members that maintain a distallyextending position, such as two imaging members with one imaging memberextending through the valve at each corner or end of the valve, mayprovide the orientation information of the valve for the physician. Theother imaging members that do not extend through the valve will bereadily apparent as the other imaging members may be moving due to thevalve opening and closing or positioned laterally relative to thetreatment device and along the periphery of the valve, such as adjacentto the posterior and anterior portions of the valve annulus. In thismanner, the treatment device may include multiple imaging members suchthat some of the multiple imaging members may provide imaginginformation as to the orientation of the valve so that a physician canappropriately treat an intended portion of the valve, such as theposterior portion of a valve annulus.

While the invention may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the invention is not intended tobe limited to the particular forms disclosed. Rather, each embodimentdisclosed herein may incorporate portions of the various embodimentsdisclosed herein. As such, the invention includes all modifications,equivalents, and alternatives falling within the spirit and scope of theinvention as defined by the following appended claims.

What is claimed is:
 1. A medical device system for treating a valve in aheart to minimize valve regurgitation, the medical device systemcomprising: a radio frequency energy source; a handle operativelycoupled to the radio frequency energy source, the handle including anactuation member and an engaging switch, the actuation member configuredto actuate with linear movement and rotatable movement; a treatmentcatheter coupled to the handle, the treatment catheter extending betweena proximal end and a distal end and including a lumen defined along alength of the treatment catheter; a first sleeve and a second sleeveeach extending through the lumen of the treatment catheter, the firstand second sleeves moveable between a constrained position and anexpanded position, the first sleeve including a first electrode and thesecond sleeve including a second electrode, the first sleeve and thesecond sleeve being biased away from each other such that, upon beingmoved to the expanded position, the first and second sleeves splayoutward to exhibit a v-configuration; a tubular sleeve extending throughthe lumen of the treatment catheter and coupled to the actuation memberof the handle, the tubular sleeve defining a sleeve lumen therein, thefirst sleeve and the second sleeve each extending through the sleevelumen of the tubular sleeve, wherein, upon engagement of the engagingswitch, rotation of the actuation member of the handle simultaneouslyrotates each of the tubular sleeve and the first and second sleevesrelative to the treatment catheter; and a sheath defining a sheath lumenalong a length of the sheath, the sheath lumen configured to provide apathway to position the distal end of the treatment catheter adjacentthe valve.
 2. The medical device system of claim 1, wherein the firstand second electrodes are each independently moveable between a proximalposition and a distal position.
 3. The medical device system of claim 1,wherein the first electrode and the second electrode each comprise ahelical configuration.
 4. The medical device system of claim 3, whereinthe first and second electrodes are each independently rotatablymoveable such that the helical configuration of each of the first andsecond electrodes is configured to twist into and out of the valvetissue.
 5. The medical device system of claim 1, wherein the firstelectrode and the second electrode each include a pointed distal tip. 6.The medical device system of claim 1, wherein the first electrode andthe second electrode each comprise a needle configuration.
 7. Themedical device system of claim 1, wherein the tubular sleeve is moveableproximally and distally relative to the first and second sleeves so asto move the first and second sleeves between the constrained positionand the expanded position.
 8. The medical device system of claim 7,wherein, upon the tubular sleeve being moved proximally relative todistal ends of the first and second sleeves, the distal ends of thefirst and second sleeves are a predetermined distance from each other.9. The medical device system of claim 8, wherein the predetermineddistance between the distal ends of the first and second sleeves in theexpanded position is dependent upon a position of a distal end of thetubular sleeve relative to the distal ends of the first and secondsleeves.
 10. The medical device system of claim 1, wherein the firstelectrode and the second electrode are each coupled to the radiofrequency energy source.
 11. The medical device system of claim 1,wherein the treatment catheter is configured to be steerable along adistal portion of the treatment catheter such that the distal portion ismoveable to multiple orientations.
 12. The medical device system ofclaim 1, further comprising an imaging member sized and configured to bepositioned within the valve and configured to provide imaginginformation regarding valve orientation relative to the treatmentcatheter.
 13. The medical device system of claim 1, wherein thetreatment catheter comprises one or more temperature sensors.
 14. Themedical device system of claim 1, wherein the treatment cathetercomprises a third sleeve configured to extend between the first andsecond sleeves, the third sleeve including a temperature sensorconfigured to sense tissue temperature.
 15. The medical device system ofclaim 13, further comprising a controller coupled to the radio frequencyenergy source and the one or more temperature sensors.
 16. The medicaldevice system of claim 13, wherein the one or more temperature sensorsare associated with each of the first electrode and the secondelectrode.
 17. The medical device system of claim 1, further comprisingan imaging member including a first shoulder portion and a secondshoulder portion with a head portion extending therebetween, the imagingmember sized and configured to be positioned within the valve such thata distal end of the tubular sleeve is positionable adjacent to the firstand second shoulder portions.
 18. A medical device system for treating avalve in a heart to minimize valve regurgitation, the medical devicesystem comprising: a radio frequency energy source; a handle operativelycoupled to the radio frequency energy source, the handle including anactuation member and an engaging switch, the actuation member configuredto actuate with linear movement and rotatable movement; a treatmentcatheter coupled to the handle, the treatment catheter extending betweena proximal end and a distal end and including a lumen defined along alength of the treatment catheter; a tubular sleeve extending through thelumen of the treatment catheter between the actuation member of thehandle and the distal end of the treatment catheter, the tubular sleevedefining a sleeve lumen therein; and a first sleeve and a second sleeveeach extending through the lumen of the treatment catheter and eachextending through the sleeve lumen of the tubular sleeve, the first andsecond sleeves moveable between a constricted position and an expandedposition, the first sleeve including a first electrode and the secondsleeve including a second electrode; wherein the first and secondelectrodes each comprise a helical configuration with a sharp distal tipconfigured to twist into tissue of the valve; wherein the first andsecond electrodes are each independently moveable relative to each otherwith linear and rotational movement; and wherein, upon engagement of theengaging switch, rotation of the actuation member of the handlesimultaneously rotates each of the tubular sleeve and the first andsecond sleeves relative to the treatment catheter.
 19. The medicaldevice system of claim 18, wherein, upon being moved to the expandedposition, the first and second sleeves splay outward from each other toexhibit a v-configuration.
 20. The medical device system of claim 18,wherein the first and second electrodes are operable in at least one ofa bipolar mode and a unipolar mode.
 21. The medical device system ofclaim 18, wherein the first and second sleeves are moveable proximallyand distally relative to the tubular sleeve.
 22. The medical devicesystem of claim 18, wherein the first and second sleeves are eachindependently moveable proximally and distally relative to the tubularsleeve.
 23. The medical device system of claim 18, wherein, uponengagement of the engaging switch, the first and second sleeves areconfigured to rotatably move together so as to pivot about one of thefirst and second sleeves with one of the first and second electrodesbeing secured to tissue and another one of the first and secondelectrodes being moved to a proximal position.
 24. The medical devicesystem of claim 18, wherein the treatment catheter comprises one or moretemperature sensors.
 25. The medical device system of claim 18, whereinthe treatment catheter comprises a third sleeve configured to extendbetween the first and second sleeves, the third sleeve including atemperature sensor configured to sense tissue temperature.
 26. Themedical device system of claim 24, further comprising a controllercoupled to the radio frequency energy source and the one or moretemperature sensors.
 27. The medical device system of claim 24, whereinthe one or more temperature sensors are associated with each of thefirst electrode and the second electrode.
 28. The medical device systemof claim 18, further comprising an imaging member including a firstshoulder portion and a second shoulder portion with a head portionextending therebetween, the imaging member sized and configured to bepositioned within the valve such that a distal end of the tubular sleeveis positionable adjacent to the first and second shoulder portions.